510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191134IB3D AlifMedicrea International SA20191—
+6K1803473d CageFims Co., Ltd.20190—
+6K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+6K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K190380nvcNvision Biomedical Technologies, Inc.20193—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K181899Roccia® PlifSilony Medical GmbH20180—
+6K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181397DualXInnovasive, Inc.201815—
+6K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K172480icotec Interbody Cage SystemIcotec AG20185—
+6K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K171312FortiCore®Nanovis, LLC20183—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K173702Juliet Ti LLSpineart20182—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172424Velofix™ SA Cervical CageU&I Corporation201751
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K160547Cascadia Interbody SystemK2m2016157—
+6K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K152568C-VBRCardinal Spine, LLC201657—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—